INTRON A PLUS RIBAVIRIN IN PEDIATRIC HEPATITIS C

$0M01FY2000RRNIH

Children'S Hospital Of Philadelphia, Philadelphia PA

Investigators

Linked publications & trials

Paper 37402774 Paper 35135359 Paper 35118727 Paper 34886679 Paper 34356046 Paper 33093519 Paper 32795677 Paper 32561914 Paper 32516339 Paper 31729158 Paper 31314787 Paper 31141530 Paper 30372552 Paper 30265344 Paper 28743860 Paper 28468790 Paper 26885808 Paper 26585995 Paper 26226985 Paper 26092599 Paper 25882907 Paper 25683819 Paper 25232777 Paper 25130421 Paper 24777943 Paper 24677430 Paper 24345827 Paper 23802135 Paper 23628837 Paper 23604262 Paper 23439301 Paper 23427188 Paper 23382092 Paper 23360096 Paper 22621754 Paper 22383118 Paper 22357070 Paper 22010865 Paper 21987465 Paper 21940205 Paper 21917867 Paper 21874618 Paper 21385513 Paper 21311500 Paper 21256423 Paper 21254360 Paper 21087573 Paper 21036173 Paper 20506525 Paper 20437614 Paper 20418300 Paper 20338795 Paper 20194709 Paper 20138299 Paper 20123264 Paper 20111745 Paper 20103654 Paper 20031554 Paper 19969305 Paper 19947855 Paper 19933732 Paper 19857355 Paper 19855250 Paper 19841125 Paper 19812581 Paper 19779474 Paper 19778749 Paper 19777601 Paper 19750922 Paper 19703674 Paper 19667944 Paper 19660971 Paper 19560477 Paper 19344194 Paper 19328266 Paper 19307814 Paper 19171714 Paper 19112531 Paper 19101853 Paper 19090330 Paper 19033189 Paper 19028390 Paper 19026647 Paper 19016583 Paper 18831064 Paper 18755325 Paper 18725060 Paper 18703961 Paper 18687424 Paper 18658113 Paper 18565443 Paper 18555484 Paper 18553493 Paper 18535546 Paper 18534620 Paper 18524659 Paper 18457241 Paper 18385794 Paper 18381540 Paper 18363317

Abstract

These protocols include a screening protocol (1693 a) and a treatment protocol (1693 b) for pediatric patients with chronic hepatitis C. Screening involved only documenting the presence of the virus and the review or performance of a liver biopsy, if not done in the previous year, to confirm the presence of chronic hepatitis. Baseline thyroid function, anti-nuclear antibody and chemistry and hematology tests were done to document their being normal before commencing treatment which might cause these values to become abnormal. Four patients enrolled and passed this screening study and were enrolled in the treatment study (1693 a). The screeniong study is now closed at all sites for this multi-centered trial. The purpose of the treatment study which was a phase 1 study, was to find the optimum and safe dose among three doses of Ribavirin at 8, 12 and 15 mg/kg/day assigned randomly and paired with treatment of all patients with interferon at 3 million IU/square meter surface area. The other aim was to define in children, the pharmacokinetics and pharmacodynamics of these drugs, data for which was only previously available in adults, to aid in choosing an optimal, tolerated and safe dose for the two drugs in children.

View original record on NIH RePORTER →